Cleared Traditional

K081382 - DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786

K081382 is an FDA 510(k) clearance for DUCKWORTH & KENT, manufactured by Duckworth & Kent, Ltd.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K081382 · Duckworth & Kent, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
160d
Days
Class 1
Risk

K081382 is an FDA 510(k) clearance for the DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on October 23, 2008 after a review of 160 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Duckworth & Kent, Ltd. devices

FDA 510(k) Submission Details - K081382

510(k) Number K081382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2008
Decision Date October 23, 2008
Days to Decision 160 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 110d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 19
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